Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06501807

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

Led by University Hospital, Lille · Updated on 2026-05-18

900

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) affects 2-4% of people in western countries and significantly reduces quality of life. This condition involves a specific immune response leading to inflammation and nasal polyps. Researchers are evaluating biologic treatments that target these immune pathways to better manage CRSwNP, aiming to improve patient quality of life and tailor treatments using biomarkers in this prospective study. The study monitors patients with severe CRSwNP who receive biologic drugs such as dupilumab, mepolizumab, or benralizumab given by subcutaneous injection every two weeks or every month, depending on marketing approvals. Some patients already treated since August 2021 will have their past clinical and biological data collected retrospectively. The study plans a follow-up period of 5 years to assess treatment impact and tolerance. Participants will provide patient-reported outcomes regularly, with evaluations at treatment start, 3 months, 6 months, and every 6 months up to 5 years. Researchers will track quality of life changes, symptom progression, time to any surgical procedures, and blood markers including eosinophil count and total IgE levels. This detailed monitoring aims to understand how biologic therapies affect CRSwNP over the long term and ensure patient safety and compliance.

CONDITIONS

Brief Title

BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old requiring biologic treatment for CRSwNP as approved
  • Patients already treated since August 2021 with available clinical and biological data
Not Eligible

You will not qualify if you...

  • Oral corticosteroid use within the previous month
  • Biologic treatment with anti-IgE, anti-IL-5/IL-5R, anti-IL-4/IL-13R, or other biotherapies for inflammatory diseases in the 6 months before treatment start, except for severe asthma or CRSwNP
  • Hypersensitivity to humanized antibodies
  • Documented COVID-19 infection in the last 3 months with ongoing smell disorders
  • Pregnant or breastfeeding women
  • Patients without social coverage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 5 years

Participants receive biologic treatments for Chronic Rhinosinusitis with Nasal Polyps according to marketing approval, administered subcutaneously every month or every two weeks.

Visits at Month 0, Month 3, Month 6, and every 6 months thereafter until 5 years

Trial Site Locations

Total: 2 locations

1

CHU de Lille

Lille, France

Active, Not Recruiting

2

chu de Lille

Lille, France

Actively Recruiting

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Research Team

G

Geoffrey Mortuaire, MD, pHD

G

Geoffrey Mortuaire

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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